Results

The proportion of pts with PD-L1 expression ≥5% was 26% (92/358) for NIVO + IPI and 29% (139/474) for NIVO. Pt characteristics were similar between PD-L1 subgroups, although fewer pts had LDH > ULN in the PD-L1 ≥5% subgroup. Among pts with PD-L1 expression ≥5%, mPFS of NIVO + IPI was not reached (NR) and was 22.0 mos for NIVO alone (hazard ratio [HR]: 0.99, 95% CI: 0.66&boxh;1.46). For pts with low to no PD-L1 (

Conclusions

While pts with ≥5% PD-L1 tumor expression have better efficacy outcomes, those with

Clinical trial identification

NA

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

G.V. Long: Served as a consultant for GSK, Roche, Novartis, BMS, Amgen, and Merck, and received honoraria from Merck, GSK, Roche. J. Larkin: Institution received research funding from Pfizer, BMS, Novartis, MSD. P.A. Ascierto: Received honoraria from BMS, Roche-Genentech, and GSK, served as a consultant for BMS, Roche-Genentech, MSD, GSK, Ventana, Novartis, and Amgen, and institution received research funding from BMS, Roche-Genentech, and Ventana. F.S. Hodi: Served as a consultant from BMS (non-paid), institution received research funding from BMS, and his institution has a patent pending for immune target. P. Rutkowski: Honoraria from BMS, Roche, Novartis, MSD, and GSK, consulted for BMS, Amgen, Roche, and MSD, participated in speaker's bureau for Pfizer, MSD and Novartis, institution received research funding from BMS, and received travel support from Novartis. V. Sileni: Served as a consultant for Roche, BMS, GSK, and MSD, participated in speaker's bureau for Roche, BMS and GSK, and received travel support from Roche, GSK, MSD, and BMS. J. Hassel: Received honoraria from BMS, GSK, Roche, MSD, and Amgen, served as a consultant for Amgen and GSK, participated in speaker's bureau for BMS, GSK, Roche, MSD, and Amgen, and received travel support from Amgen and BMS. C. Lebbe: Dr. Lebbe served on advisory boards for BMS, MSD, Roche, GSK, Novartis. A.C. Pavlick: Served as a consultant for BMS and Amgen, and participated in speaker's bureau for BMS. J. Wagstaff: Served as a consultant for BMS. D. Schadendorf: Honoraria: Roche, GSK, Amgen, Novartis, BMS, MSD; consultant: Roche, GSK, Amgen, Novartis, BMS, MSD; speakers bureau: Roche, GSK, Amgen, Novartis, BMS, MSD; institutional research funding: MSD, and travel from Roche, GSK, Amgen, Novartis, BMS, MSD. R. Dummer: Paid honoraria from Roche, BMS, GSK, MSD, and Novartis, served as a consultant for Roche, BMS, GSK, MSD, and Novartis, received research funding from Roche, BMS, GSK, MSD, and Novartis. D. Hogg: Served as a consultant for BMS, Roche, Novartis and GSK. J.B.A.G. Haanen: Served as a consultant for MSD, Roche and Pfizer, received research funding from BMS and GSK. P. Corrie: Paid honoraria from Roche, BMS, GSK, and Celgene, served as a consultant for Roche, BMS, Merck, GSK, and Celgene, and received travel support from BMS, Merck and Roche. C. Hoeller: Paid honoraria from BMS, MSD, Roche, Novartis, Amgen and GSK, served as a consultant for BMS, MSD, Roche and Amgen, received research funding from BMS, MSD, Roche, Novartis, and GSK. C. Horak: Employed by BMS and owns stock in BMS. J. Wolchok: Honoraria: EMD Serono, Janssen Oncology; consultant: BMS, Merck, MedImmune, Ziopharm, Polynoma, Polaris, Jounce, GSK; institutional research funding: BMS, MedImmune, GSK, Merck; co-investor in patent for DNA vaccines of cancer in animals; travel: BMS. C. Robert: Paid honoraria from BMS, Merck, GSK, Roche, Novartis and Amgen, served as a consultant for BMS, Merck, GSK, Roche, Novartis, and Amgen.